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MALAYSIA: MDA ANNOUNCED TRANSITION PERIOD OF REGISTRATION APPLICATION WITH EXEMPTION FROM COMPLIANCE ASSESSMENT PROCESS BY COMPLIANCE ASSESSMENT BODY (CAB) FOR REGISTRATION OF COVID-19 TEST KITS. — SEPTEMBER/OCTOBER 2023

MALAYSIA: MDA ANNOUNCED TRANSITION PERIOD OF REGISTRATION APPLICATION WITH EXEMPTION FROM COMPLIANCE ASSESSMENT PROCESS BY COMPLIANCE ASSESSMENT BODY (CAB) FOR REGISTRATION OF COVID-19 TEST KITS. — SEPTEMBER/OCTOBER 2023

  • 2023-09-27 06:46:28

The Medical Device Authority (MDA) announced transitional period on July 14th for the registration of Covid-19 test kits, which the registration applications would be subjected to the compliance assessment procedure conducted by the compliance assessment body (CAB).

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QT ANALYSIS: UPDATE IN THE CYBERSECURITY REGULATIONS OF MEDICAL DEVICES IN ASIA (CHINA, JAPAN, SINGAPORE) — AUGUST/SEPTEMBER 2023

QT ANALYSIS: UPDATE IN THE CYBERSECURITY REGULATIONS OF MEDICAL DEVICES IN ASIA (CHINA, JAPAN, SINGAPORE) — AUGUST/SEPTEMBER 2023

  • 2023-08-23 06:27:14

Qualtech highlights the critical role of cybersecurity in safeguarding medical devices and patient well-being, emphasizing the potential risks posed by connectivity and the need for stringent measures to counteract vulnerabilities. We emphasize the collaborative efforts required among medical device stakeholders to establish and maintain robust security standards. This QT analysis revisits a previous cybersecurity article with a focus on recent developments in Japan, China, and Singapore.

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CHINA: FORWARD THE NOTICE OF THE NATIONAL ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE STANDARDIZATION TECHNICAL COMMITTEE ON CARRYING OUT A SURVEY FOR THE IMPLEMENTATION OF GB 9706.224-2021 AND GB 9706.1-2020 — AUGUST/SEPTEMBER 2023

CHINA: FORWARD THE NOTICE OF THE NATIONAL ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE STANDARDIZATION TECHNICAL COMMITTEE ON CARRYING OUT A SURVEY FOR THE IMPLEMENTATION OF GB 9706.224-2021 AND GB 9706.1-2020 — AUGUST/SEPTEMBER 2023

  • 2023-08-23 06:16:37

Center for Medical Device Standardization Administration NMPA forwarded the notice of the National Electrical Equipment In Medical Practice Standardization Technical Committee on carrying out a survey for the implementation of the GB 9706.224-2021 "Medical Electrical Equipment Part 2-24: Special Requirements for Basic Safety and Basic Performance of Infusion Pumps and Infusion Controllers" and GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance".

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MALAYSIA: MDA ANNOUNCED A NEW APPROACH TO EXPIRED EC CERTIFICATES FOR NEW REGISTRATION AND RE-REGISTRATION OF MEDICAL DEVICE — AUGUST/SEPTEMBER 2023

MALAYSIA: MDA ANNOUNCED A NEW APPROACH TO EXPIRED EC CERTIFICATES FOR NEW REGISTRATION AND RE-REGISTRATION OF MEDICAL DEVICE — AUGUST/SEPTEMBER 2023

  • 2023-08-23 06:00:06

The Medical Device Authority's (MDA) approach to expired EC Certificates for New Registration and Re-Registration of Medical Devices has been loosened. In line with Directives 90/385/EEC and 93/42/EEC, MDA recognizes the EC Certificate (CE Marking) as one of the approved types of conformity assessment procedures by way of verification process for the purpose of medical device registration in Malaysia.

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